Occlusion of Fontan fenestrations using the Amplatzer septal occluder

Objective—To evaluate the efficacy and safety of the Amplatzer septal occluder device for occlusion of Fontan fenestrations.
Subjects—Five children aged 5-10 years who had undergone a fenestrated Fontan operation.
Setting—Tertiary paediatric cardiology centre.
Methods—Each patient had right and left heart catheterisation to assess haemodynamic suitability for fenestration closure. Sizing of the defect was achieved with a balloon wedge catheter and transoesphageal echocardiography. Transcatheter occlusion of the fenestration was accomplished using a 4 mm device in three patients, and 5 mm or 9 mm devices in the other two patients. Residual shunting following occlusion was assessed using angiography and echocardiography.
Results—100% occlusion rate of the fenestration was achieved in all patients. No complications or device failures were seen during the three month follow up period.
Conclusion—The Amplatzer septal occluder device is safe, and effectively occludes the Fontan fenestration.

Keywords: Fontan circulation;  fenestration occlusion;  Amplatzer septal occluder device;  congenital heart disease     

Closure of a moderately large atrial septal defect with a self-fabricated fenestrated Amplatzer septal occluder in an 85-year-old patient with reduced diastolic elasticity of the left ventricle.

Percutaneous closure of an atrial septal defect (ASD) in the elderly with reduced diastolic elasticity of the left ventricle poses a significant management challenge. We report on the case of an 85-year-old patient who was admitted for percutaneous device closure of a moderately large secundum atrial septal defect. Hemodynamic evaluation documented an increase in left atrial pressure from a mean of 12 mm Hg to a mean of 32 mm Hg after balloon test occlusion of the ASD. Two months later, after adequate pretreatment with diuretics and afterload-reducing substances, he underwent successful closure of the ASD using a self-fabricated fenestrated Amplatzer septal occluder, which resulted in a postimplantation left atrial pressure of a mean of 18 mm Hg. Recovery was unremarkable and the fenestration has remained patent for 3 months since implantation of the device. This unique case highlights the feasibility of using a self-fabricated fenestrated Amplatzer septal occluder to close interatrial communications in elderly patients with diastolic dysfunction of the left ventricle.     

Shunt reduction with a fenestrated Amplatzer device

Background : In specific high‐risk patients with congenital heart disease (CHD), a complete closure of an intracardiac defect/shunt is not possible for a variety of reasons. We report our experiences with an interventional approach for shunt‐reduction using various modifications of a self‐fabricated Amplatzer device in our institution. Methods : Retrospective analysis of patients with CHD having received an interventional partial shunt occlusion since 09/2005. Results : Five patients, mean age 18.6(3.4–66) years, mean weight 36.4(14–102) kg, have been treated. In three patients (3.4, 3.9, 66 years) with an atrial septal defect (ASD) and a restrictive left ventricle (LV) (n = 1) or pulmonary arterial hypertension (PAH) (n = 2), respectively, an Amplatzer Septal Occluder (ASO) with a predilated (n = 2) or a presutured (n = 1) central hole was implanted. After successful immediate volume release in all, the balloon‐dilated holes closed spontaneously during mid‐term follow‐up, pulmonary artery (PA) pressure and LV function remained normal. Two patients (2.7 and 17 years) with a Fontan circulation and severe cyanosis (saturation ≤80%) due to a large fenestration and elevated PA pressures received a partial occlusion of their shunt by implanting a centrally stented ASO or Amplatzer Vascular plug. After a follow‐up of 31 and 39 months both stents remained patent under oral anticoagulation, oxygen saturation remained >85% with PA pressures unchanged, and both patients were in good clinical conditions. Conclusions : In patients with an ASD and significant PAH and/or restrictive LV physiology as well as in Fontan patients with a large surgically created fenestration but failing Fontan circulation, a partial closure with a self‐fenestrated Amplatzer device can be a feasible and successful therapeutic option. Balloon‐dilated fenestrations in the Amplatzer device tend to close spontaneously during follow‐up. Nonresorbable sutures or stenting can ensure patency of the created holes. © 2010 Wiley‐Liss, Inc.     

Home-made fenestrated amplatzer occluder for atrial septal defect and pulmonary arterial hypertension

We report the management of a patient with secundum atrial septal defect (ASD) and severe pulmonary hypertension. A 65-year-old male with recently diagnosed atrial septal defect was referred to our centre for decompensated right heart failure with rest and exercise induced dispnea and severe pulmonary hypertension. Right heart catheterization confirmed a mean pulmonary pressure of about 55 mmHg and a Qp/Qs of 2.7. An occlusion test with a compliant large balloon demonstrated partial fall of pulmonary arterial pressure. The implantation of a home-made fenestrated Amplatzer ASD Occluder (ASO) was planned in order to decrease left-to-right shunt and promote further decrease of pulmonary arterial pressure in the long-term. Thus, by means of mechanical intracardiac echocardiography study with a 9F 9 MHz UltraIce catheter (Boston Scientific Corp.), we selected a 34 mm ASO for implantation. Four millimeter fenestration was made inflating a 4 mm non-compliant coronary balloon throughout the waist of the ASO, which was successfully implanted under intracardiac echocardiography. After six months, a decrease of pulmonary arterial pressure to 24 mmHg and full compensated right heart failure was observed on transthoracic echocardiography and clinical examination. This case suggests that transcatheter closure with home-made fenestrated ASD in elderly patients with severe pulmonary hypertension is feasible.     

Fate of a modified fenestration of atrial septal occluder device after transcatheter closure of atrial septal defects in elderly patients

Background: Data on closure of atrial septal defects (ASD) in elderly patients with a fenestrated Amplatzer septal occluder (ASO) device is limited. Methods: A hemodynamically significant ASD was closed with a fenestrated ASO in 3 patients with ages >62 years. Prior to implant a 4‐mm fenestration was created by balloon dilatation without additional suture fixation just adjacent to the stent part of the device. Indications for fenestration were restrictive left ventricular physiology and/or pulmonary hypertension. Heparin had been administered during and for 48 hours after the procedure. Two patients were maintained on phenprocoumon because of chronic atrial fibrillation, the remaining patient on aspirin and clopidogrel for 3 months after implant. Transesophageal echocardiography (TEE) and hemodynamic evaluation were performed 4–18 months after ASD closure. Results: A trace or small fenestration through the ASO with left‐to‐right shunt was detected by TEE in all 3 patients without any hemodynamic significance. No thrombus formation was observed. Pulmonary hypertension improved in the affected patient. Pulmonary arterial wedge pressure and cardiac index improved in the second patient with improvement in heart failure symptoms and of quality of life in both. The third patient, after initial improvement for 6 months, developed significant comorbidities and clinical deterioration at 18 months follow‐up. Conclusion: The modified fenestration of the ASO decreased significantly in size at follow‐up. Applying this technique to selected patients judged to be at risk for ASD closure avoids acute decompensation and allows gradual diminuition of right ventricular volume overload during mid‐term follow‐up. (J Interven Cardiol 2011;24:485–490)     

ASD closure with the Amplatzer device

We report the safety and efficacy of the Amplatzer device for transcatheter closure of ASD and fenestrated Fontan in children and adults. One hundred and two patients underwent transcatheter occlusion of the defect. The median age of the patients was 18.2 years, the median size of the ASDs by TEE was 17.6 mm, the median balloon-stretched diameter was 19.9 mm, and the median size of the device implanted was 20 mm. Immediately after the release of the device, color Doppler echocardiography revealed no residual shunt in 92 (90.19%) of 102 patients. At 24 hours all the patients 101/101 (100%) had complete closure. The minor complications encountered after the procedure were atrial arrhythmias in 4 patients. The only major complication we had was a baby who died. In conclusion, the ASO device is a safe and effective device for catheter closure of most secundum ASDs and fenestrated Fontan.     

Fenestrated Amplatzer device for percutaneous creation of interatrial communication in patients after Fontan operation.

A customized Amplatzer septal device with a 5 mm fenestration was used to create an interatrial communication in two patients with previous Fontan operation and clinical indication for fenestration. At follow-up, device fenestration was occluded in both patients. In both patients, the device fenestration was reopened and patency maintained by placement of two stents within the communicating channel.     

超声心动图在成人房间隔缺损治疗决策中的作用

目的　探讨超声心动图在成人房间隔缺损(ASD)治疗决策中的作用 ,选择适合的病例进行经皮导管堵闭治疗。方法　本组资料来源于 2 0 0 2年 8月至 2 0 0 3年 8月广东省心血管病研究所 ,12 8例患者经胸超声心动图 (TTE)诊断为继发孔型ASD ,使用TTE筛选和患者同意的 5 2例进行导管堵闭治疗 ,78例患者进行了外科手术治疗。结果　经超声心动图筛选的病例 ,导管介入治疗能有效地关闭 96 %(5 0 /5 2 )的继发孔型ASD ,外科手术修补房间隔缺损的成功率为 10 0 % ,超声心动图显示的房间隔缺损分型与外科术中分型的差异无显著的统计学意义 (P >0 0 5 )。结论　经胸超声心动图能准确的显示成人ASD解剖变异和确定分型 ,经皮导管介入治疗能成功地堵闭绝大多数经超声心动图筛选的患者     

Failed transcatheter creation of fenestration in a Fontan patient with original fenestration closed by AngelWings septal occluder: a case report

The fenestrated Fontan procedure has helped to reduce the mortality and morbidity of pediatric patients who underwent the Fontan operation. We treated a patient (7-year-old, female) who had developed heart failure 1 year after fenestration closure using an AngelWings device, although the patient met the proposed criteria for test occlusion. Hemodynamic evaluation using the ventricular pressure-area relationship revealed that the patient had both systolic and diastolic dysfunction, which were difficult to recognize by conventional hemodynamic indices. We then tried to percutaneously create a fenestration using a Brockenbrough needle, but this procedure failed. The AngelWings device, which may have been covered by pseudointima (composed of fibroelastic tissue), was hard enough to break the Brockenbrough needle. Re-creating a fenestration after device closure in patients after the fenestrated Fontan operation appears to be difficult, so more accurate methods to predict Fontan physiology after fenestration closure are needed.     

Closure of extrocardiac Fontan fenestration by using the Amplatzer duct occluder

INTRODUCTION: A direct or tubular communication between the systemic venous system and the systemic atrium, generally called fenestration, is surgically created to improve the postoperative period of patients undergoing total cavopulmonary connection. However, a fenestration prompts a potentially deleterious right to left shunt, and is generally closed after the postoperative period. Direct fenestrations can be closed using coils, or devices designed for atrial septal defect closure. However, no devices have been designed for closure of extracardiac fenestrations. We report our experience concerning the closure of extracardiac Fontan fenestration by the Amplatzer duct occluder (ADO). METHODS: From January 2001 to December 2002, we closed extracardiac Fontan fenestrations using the ADO device in 10 consecutive patients. Indications to fenestration closure were: low velocity shunt through the fenestration, mild desaturation, and absence of effusions. RESULTS: All patients had a successful closure of the fenestration. The procedure was performed through the femoral vein in 7 cases and through the right jugular vein in 3. Mean central venous pressure increased not significantly from 12 to 13-mmHg. Mean oxygen saturation increased significantly from 90 to 97% (p<0.001). Immediate shut abolition was obtained in 9 cases. No complications were observed. At a median follow-up of 12 months (range 6-18 months), all patients are free of symptoms and have a normal oxygen saturation at rest as well as at exertion. CONCLUSION: The ADO device allowed closing the extracardiac Fontan fenestration in all patients with no mortality, no morbidity and a rate of 100% of complete closure at mid-term follow-up.     

Aortic sinus-left atrial fistula after interventional closure of atrial septal defect.

A 3-year-old boy underwent interventional closure of an atrial septal defect using an Amplatzer septal occluder. After 4 weeks, an aortic sinus-to-left atrial fistula was detected by echocardiography in an asymptomatic child. The device was surgically explanted with fistula and atrial septal defect closure. Follow-up was uneventful.     

Transcatheter closure of fontan fenestrations using the Amplatzer septal occluder: initial experience and follow-up.

We have recently used the Amplatzer septal occluder to close Fontan fenestrations. Between June 1998 and December 1999, 13 patients underwent transcatheter occlusion of their Fontan fenestrations. Systemic blood flow decreased significantly without a concomitant decrease in pulmonary blood flow. All residual shunts detectable by oximetry were at sites separate from those into which occlusion devices were implanted. One patient developed severe tricuspid regurgitation following the procedure requiring surgical removal of the device. At the last follow-up, all patients were doing well clinically. There were no shunts detectable through or around the devices by echocardiography. Our experience indicates that the location of the fenestration within the Fontan baffle is critical to avoiding device interference with other intracardiac structures. The Amplatzer septal occluder offers an effective means of transcatheter closure of Fontan baffle fenestrations. Although more experience is needed, our current follow-up data suggest that long-term outcomes will be favorable. Cathet. Cardiovasc. Intervent. 51:301-304, 2000.     

彩色超声心动图监测经导管蘑菇伞堵闭房间隔缺损的作用评价

目的 使用彩色超声心动图监测经导管蘑菇伞堵闭先天性心脏病房间隔缺损(ASD)。方法 使用彩色超声心动图仪器对14岁以下小儿经食道,成人经胸术中监测,指导操作者安置封堵器的合适方位。当双盘蘑菇伞腰部卡在ASD内,两盘则分别在左、右房侧时,彩色超声心动图监测无残余分流后结束堵闭术,术后24小时再次进行彩色超声心动图检查。结果 37例中,36例1次堵闭成功,1例失败。结论 在经导管蘑菇伞堵闭ASD中,彩色超声心动图监测很重要。     

Device closure of fenestrated atrial septal defects: use of a single Amplatz atrial septal occluder after balloon atrial septostomy to create a single defect.

Successful transcatheter device closure of secundum atrial septal defect has achieved worldwide acceptance with the clinical use of the Amplatz atrial septal occluder. However, device closure of multiple fenestrated secundum atrial septal defects remains a challenge for the interventionist and in some cases may be only effectively closed surgically. This case report of multiple fenestrated atrial septal defects represents a further expansion of technologic efforts to improve the results and simplify the mechanism of device closure of fenestrated defects. When device closure with more than one device seems impractical or disadvantageous, consolidation of multiple defects in a fenestrated fossa ovalis by simple balloon atrial septostomy as demonstrated by this case report provides an easy mechanism to allow implantation of a single large device which will effectively close all of the defects. This approach is similar to the surgical approach for resection of the fenestrated membrane with secondary patch closure of the enlarged defect. Excellent and complete closure of a fenestrated secundum atrial septal defect is illustrated in this case report.     

Long-term follow-up of a fenestrated Amplatzer atrial septal occluder in pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH) is a progressive disease, with right-heart failure being the main cause of death. In patients refractory to conventional drug therapy, atrial septostomy can serve as palliative treatment or as a bridge to transplantation. A 41-year-old woman with a 15-year history of PAH associated with a corrected atrial septal defect presented with severe deterioration of symptoms. Echocardiography confirmed reocclusion of an atrial septal stoma that had been created several months before. After performing a repeat atrial septostomy, we implanted a custom-made atrial septostomy device, an Amplatzer septal occluder that had been fenestrated to serve as a custom-made atrial septostomy device. This resulted in an improvement in cardiac output and a marked symptomatic relief. During the 6-year follow-up, the patient was clinically stable with limited but constant exercise tolerance, under specific medical therapy. Repeated echocardiography confirmed long-term patency of the device.     

Influence of atrial septal defect anatomy in patient selection and assessment of closure with the Cardioseal device; a three-dimensional transoesophageal echocardiographic reconstruction.

BACKGROUND: The maximal diameter of the defect and the dimensions of the septal rims are essential parameters for the selection of optimal cases for device closure. Neither two-dimensional echocardiography nor balloon catheter sizing provide optimal data. Unique three-dimensional echocardiography might help to improve patient selection and assessment of results. Our aim was to optimize transcatheter closure of secundum type atrial septal defects using three-dimensional echocardiography. METHODS: Sixteen patients enrolled in a protocol for atrial septal defect transcatheter closure with the Cardioseal device underwent transoesophageal two- and three-dimensional echocardiography. Maximal diameter and tissue rim of the atrial septal defect were measured and compared by both methods. In the 12 patients selected for closure, the balloon stretched diameter was compared to three-dimensional echocardiography measurements. Device placement was assessed by two- and three-dimensional echocardiography. RESULTS: The shape of the atrial septal defect appeared variable on three-dimensional views: round in nine patients but complex (oval, raquet-shaped, multiple) in seven patients. The surface area of the atrial septal defect varied by 68+/-15% during the cardiac cycle. The correlation between atrial septal defect maximal diameters measured by two-dimensional transoesophageal echocardiography and three-dimensional echocardiography was better in round defects (y=1 x +1.6, r=0.99) than in complex defects (y=0.7 x -0.5, r=0.88). The antero-superior rim could only be properly assessed by three-dimensional echocardiography. In 12 patients the correlation between stretched diameter and three-dimensional echocardiography maximal diameter was poor (y=0.3 x +13, r=0.41). After placement of the device, three-dimensional echocardiography enabled the mechanism of residual shunting to be understood in three patients. CONCLUSIONS: Dynamic three-dimensional echocardiography enhances the understanding of the anatomy and physiology of atrial septal defect and should be an important process in future initiatives for device closures.     

Transcatheter closure of fenestrations and excluded hepatic veins after fontan: versatility of the Amplatzer device

BACKGROUND: The aim of this study was to evaluate the Amplatzer septal occluder (ASO) for transcatheter closure of fenestrations and excluded hepatic veins in patients after modified Fontan operations. Residual right-to-left shunts have improved surgical results of the Fontan operation. Shunt closure may eventually be desirable to eliminate hypoxemia and reduce risk of embolic complications. METHODS AND RESULTS: Ten patients with hypoxemia caused by residual shunts after Fontan procedures were evaluated for closure. After favorable results of test occlusion, all shunts were closed with the use of the ASO. Eight ASOs were used to close fenestrations in 7 patients with 6F transvenous sheaths. Three ASOs were used to close excluded hepatic veins in 3 patients with 6F venous sheaths and transbaffle punctures. Fluoroscopy and transesophageal echocardiography were used to guide device placement. Device placement in all patients was successful. All shunts were closed by angiography after device placement. While breathing room air, systemic oxygen saturation rose from 87.9% +/- 3.0% to 96.3% +/- 0. 9% (P <.001) in the patients. There were no complications of the implant procedures and none noted in outpatient follow-up. CONCLUSIONS: This experience suggests that the ASO is safe and effective for closing surgical shunts after Fontan procedures. The ASO design allows closure of excluded hepatic veins and has advantages over other devices in closure of fenestrations.     

Late endocarditis of Amplatzer atrial septal occluder device in a child

Bacterial endocarditis following atrial septal defect closure using Amplatzer device in a child is extremely rare. We report a 10-year-old girl who developed late bacterial endocarditis, 6 years after placement of an Amplatzer atrial septal occluder device. Successful explantation of the device and repair of the resultant septal defect was carried out using a homograft patch. The rare occurrence of this entity prompted us to highlight the importance of long-term follow up, review the management and explore preventive strategies for similar patients who have multiple co-morbidities and a cardiac device. A high index of suspicion is warranted particularly in pediatric patients.     

Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder.

AIMS: The study was set up to find out whether a new self-centering prosthesis for transcatheter closure of secundum atrial septal defects could overcome the disadvantages of previously described devices. METHODS AND RESULTS: Fifty-two consecutive patients with a significant atrial septal defect were considered for transcatheter closure with the Amplatzer Septal Occluder. The device, made of a Nitinol and polyester fabric mesh, provides a different approach to defect occlusion by stenting the atrial septal defect up to a stretched diameter of 26 mm. Three infants whose large defects were demonstrated on a transthoracic echocardiogram were excluded from transcatheter treatment. On transoesophageal echocardiography, 49 defects ranged from 6-26 mm, in one adult the defect measured 28 mm and this patient was excluded from attempted transcatheter closure. At cardiac catheterization in five further patients, devices were not implanted, in two because the stretched diameter exceeded 26 mm and in three the device was withdrawn because it was unstable or compromised the mitral valve. Thus, device closure was performed in 43 patients. At follow-up after 3 months the complete closure rate was 97%. CONCLUSION: The self-centering Amplatzer Septal Occluder is very efficient and user-friendly and offers interventional closure in 83% of an unselected group of patients presented with an atrial septal defect.     

Transcatheter closure of atrial septal defects under echocardiographic guidance without X-ray: initial experiences.

BACKGROUND: Transcatheter closure of atrial septal defects is performed under fluoroscopy, but echocardiography has gained an important role in the procedure. With the new Amplatzer Septal Occluder a device has become available which is easy to implant with minimal fluoroscopy time. We developed an interventional procedure with this device under transesophageal echocardiography alone without fluoroscopy. METHODS AND RESULTS: Four patients (3 to 16 years of age, bodyweight 14 to 60 kg) with atrial septal defects centrally located in the oval fossa were elected for transcatheter closure. After sedation with midazolam and propofol a diagnostic and interventional catheterization was performed in all cases without fluoroscopy. Oxymetric shunt was Qp: Qs = 1.7 (1.5 to 2.1). Under transesophageal echocardiography, the defects were sized over the wire with a balloon catheter. Mean balloon stretched diameter was 10 mm (7 to 14 mm). Under transesophageal echocardiography an Amplatzer Septal Occluder was placed into the defect. In two patients this was achieved with a 5 MHz monoplane pediatric transducer, in two patients a 10mm 5 MHz multiplane probe was used. Complete closure was achieved in all patients and no complications were encountered. CONCLUSION: We conclude that in selected cases with an atrial septal defect located in the oval fossa and clear-cut echocardiographic findings, an Amplatzer Septal Occluder can be safely deployed under echocardiographic guidance alone.